Posted October 8, 2015

FDA Warns Seller of Omega-3 "Concussion" Supplement for Drug Claims

On October 1, 2015, the FDA issued a warning letter to MPH Nutrition, LLC, following a review of the company's website which found statements made about  Re:Mind Recover, a supplement promoted for recovery from concussions, to be drug claims which are not permitted for supplements. 

Re:Mind Recover  contains omega-3 fatty acids EPA and DHA from fish oil, vitamin D and protein. It is promoted for cognitive enhancement and recovery from concussions for athletes. For example, statements made in one document posted on the company's website include "While no product can prevent or quickly heal a concussion, nutrition and Omega-3's can play an important role in the recovery process." and "Re:Mind Recover makes it easy for athletes to follow Michael Lewis, MD's Omega-3 Protocol for Brain Injury to help support their recovery.

This protocol is described on another page on the website as "They designed their Re: Mind Recover omega-3 drink to make it easy for athletes and others to follow my Omega Protocol for Brain Injury ...three times a day after a concussion. Can't get more simple than that."   

MPH Nutrition was also warned for "liking" a reader's comment on the company's facebook page which stated, "For years I have been told that my brain will not heal and that I will be forced to deal with the lasting effects of my concussions. For the first time in a decade I believe that there is something that can help me, and that is Re:Mind Recover. I highly recommend this product to anyone that plays contact sports and has felt the lasting effects of a head injury. This product delivers more than relief from the effects of concussions, it provides hope that the brain can heal with the proper help. Thank you Re:Mind Recover."   

In 2014, the FDA warned consumers that no supplements have been shown to treat concussions and other brain injuries; the FDA's National Health Fraud Coordinator Gary Coody explained, "We're very concerned that false assurances of faster recovery will convince athletes of all ages, coaches and even parents that someone suffering from a concussion is ready to resume activities before they are really ready. Also, watch for claims that these products can prevent or lessen the severity of concussions or TBIs [traumatic brain injuries]." 

See ConsumerLab.com's Reviews of Fish Oil and Omega-3 Fatty Acid Supplements, Vitamin D Supplements and Protein Powders and Drinks for tests of related products.

See Related Warnings:

Beware of Supplements Claiming to Treat Brain Injury, FDA Warns

Maker of Concussion Recovery Supplement Warned For Making Drug Claims

Maker of Omega-3, Bone and Brain and Supplements Warned For Drug Claims

To read the FDA's warning letter, use the link below.